1. Field of the Invention
The present invention relates generally to surgical devices, and more particularly, to a surgical device for creating an anastomosis between first and second hollow organs, preferably between the aorta and a harvested vessel.
2. Prior Art
To perform a coronary artery bypass graft (CABG), a cardiac surgeon traditionally hand sutures the proximal and distal ends of the harvested graft vessel, which is usually a portion of the saphenous vein or radial artery. The proximal end attaches to the patient""s aorta and the distal end attaches to the diseased coronary artery, bypassing the blockage. Hand suturing the graft vessel is a time consuming procedure requiring great surgical skill, and typically requires a sternotomy or thoracotomy for access to the surgical site. Anastomosis devices have been developed which comprise a handle, which is interchangeably used with a hole puncher for creating the aortotomy, and a delivery device that is supplied with the anastomotic coupler and that must be xe2x80x9cloadedxe2x80x9d with the graft vessel prior to deployment of the vessel and coupler to the aorta. The delivery device is approximately 30 cm long and has controls for deploying the coupler and the vessel. Because of the size of these devices, cardiac surgeons may prefer to perform the proximal anastomosis to the aorta prior to the distal anastomosis to the coronary artery on the heart. Surgeons prefer this order so that loading of the vessel into the delivery device, and subsequent manipulation of the device while performing the proximal anastomosis, is not hampered by the vessel graft (only about 12-20 cm long) being already attached on its distal end to the heart.
These anastomosis devices generally have different sizes of anastomotic couplers (for differently sized graft vessels), each of which is supplied to the user in an appropriately labeled delivery device. If the surgeon should decide to open the sterile package for the delivery device containing the first size and then decides to change to the second size, or if the first device is unintentionally rendered inoperable due to misleading, etc., then the entire first device must be discarded. Also the surgeon may need to perform multiple bypasses when two or more graft vessels are anastomosed to the aorta.
The anastomosis devices of the prior art also require that the operator first assemble the punch with the handle in order to create the aortotomy. Next the punch must be removed from the handle while the distal end of the handle is held steadily in the aortotomy to prevent leakage of blood. While still holding the handle with the distal end in the aortotomy, the operator assembles the delivery device, already loaded with a graft vessel and the anastomotic coupler, into the handle. The surgeon must exchange these instrument components within the surgical opening providing access to the aorta resulting in a leakage of blood from the aorta.
Therefore it is an object of the present invention to provide a surgical device for creating an anastomosis between first and second hollow organs that allows a distal anastomosis to be more easily performed first before a proximal anastomosis, in case this is the surgeon""s preference.
It is another object of the present invention to provide a surgical device for creating an anastomosis between first and second hollow organs which has a relatively low cost component that is separate from the delivery device, contains the anastomotic coupler, and may be loaded with the graft vessel.
It is yet another object of the present invention to provide a surgical device for creating an anastomosis between first and second hollow organs wherein the remainder of the device (other than the component discussed immediately above) is reloadable and has controls that may be reset for multiple use.
It is still another object of the present invention to provide a surgical device for creating an anastomosis between first and second hollow organs, which minimizes blood leakage and/or injury to the hollow organs.
It is still another object of the present invention to provide a surgical device for creating an anastomosis between first and second hollow organs, which eliminates instrument exchanges.
Accordingly, a surgical device for creating an anastomosis between first and second hollow organs is provided. The device comprises: a housing; a punch slidingly disposed in the housing for forming a hole in the first hollow organ; a cartridge movably disposed in the housing between a cutting position and a deploying position, the cartridge having the second hollow organ and a coupler for coupling the first and second hollow organs loaded therein; punch actuation means for sliding the punch between the cutting and deploying positions, wherein while in the cutting position the punch is in position to form the hole in the first hollow organ and while in the deploying position, the punch is in position to permit the deployment of the second hollow organ; cartridge actuation means for moving the cartridge between the cutting and deploying positions, wherein while in the cutting position, the cartridge is in position to permit the punch to form the hole in the first hollow organ and while in the deploying position, the cartridge is in position to deploy the second hollow organ; and deploying means for deploying the second hollow organ and coupler into the hole while the punch and cartridge are in the deploying position to create the anastomosis.
The first hollow organ is preferably the aorta of the heart and the second hollow organ is preferably a harvested vessel. The coupler is preferably an anastomotic device having a set of pins on each of two ends, one of the sets of pins coupling the anastomotic device to a distal end of the second hollow organ and the other set of pins coupling the anastomotic device to a wall of the second hollow organ about the hole.
Preferably, the surgical device for creating an anastomosis between first and second hollow organs comprises: a housing; a punch slidingly disposed in the housing along a central axis for forming a hole in the first hollow organ; a cartridge movably disposed in the housing between a position offset from the central axis and a position aligned with the central axis, the cartridge having the second hollow organ and a coupler for coupling the first and second hollow organs loaded therein; punch actuation means for sliding the punch between cutting and deploying positions, wherein while in the cutting position the punch is in position to form the hole in the first hollow organ and while in the deploying position, the punch is in position to permit the deployment of the second hollow organ; cartridge actuation means for moving the cartridge between the cutting and deploying positions, wherein while in the cutting position the cartridge is in the position offset from the central axis and while in the deploying position, the cartridge is in the position aligned with the central axis; and deploying means for deploying the second hollow organ and coupler into the hole while the punch and cartridge are in the deploying position to create the anastomosis.
More preferably, the cartridge is rotatably disposed in the housing and the cartridge actuation means comprises; a cradle rotatably disposed in the housing for accepting the cartridge; and a shaft connected to the housing upon which the cradle rotates.
Preferably, the punch comprises: a shaft disposed along the central axis; and a punch tip disposed at a distal portion of the shaft and having a pointed surface for piercing the first hollow organ. More preferably, the punch further comprises means for retracting the pointed surface of the punch tip into a lumen of the shaft. Furthermore, the punch tip preferably has a proximal edge for cutting a wall of the first hollow organ, a grooved portion proximate to the punch tip for capturing a wall of the first hollow organ, and means for retracting the punch tip to sandwich the wall between the proximal edge and a portion of the housing and to sever the wall around a periphery of the proximal edge.
The cartridge preferably further comprises a seal for sealing liquid in the first internal organ from entering the device. The cartridge further preferably comprises a splitting means for splitting the cartridge and seal subsequent to deployment of the second hollow organ and coupler for facilitating release of the second hollow organ from the device. The coupler preferably has pins for securing the second hollow organ to the hole of the first hollow organ, the pins being biased in a bent position, where the cartridge further comprises retaining means for retaining the pins in a substantially straight position prior to deployment of the second hollow organ and coupler. In which case the deploying means preferably comprises; means for pushing a distal end of the second hollow organ and the coupler into the hole of the first hollow organ; and means for releasing the restraint on the pins thereby fixing the second hollow organ to the hole of the first hollow organ. The means for pushing the distal end of the second hollow organ and coupler into the hole of the first hollow organ preferably comprises a shaft operatively connected to the cartridge for sliding the cartridge along the central axis such that the distal end of the second hollow organ protrudes from the housing and into the hole of the first hollow organ. The means for releasing the restraint on the pins preferably comprises: a screw tube rotatably disposed in the housing and operatively connected to the cartridge; a knob connected to a distal end of the screw tube, wherein rotation of the knob releases the restraint on the pins.
The punch actuation means preferably comprises: a punch lever rotatably disposed on a shaft of the punch, wherein pulling the punch lever in the proximal direction moves the punch from the cutting position to the deploying position; and retainer means for retaining the punch lever in the housing as it is pulled in the proximal direction. Furthermore, the cartridge and punch actuation means preferably also comprise locking means for locking the cartridge, punch lever and punch in the deploying position.
Also provided is a method for creating an anastomosis between first and second hollow organs. The method comprising: providing a punch slidingly disposed in a housing along a central axis; providing a cartridge movably disposed in the housing between a position offset from the central axis and a position aligned with the central axis; loading the second hollow organ and a coupler for coupling the first and second hollow organs into the cartridge; sliding the punch distally to create a hole in a wall of the first hollow organ; sliding the punch proximally to provide clearance for rotation of the cartridge into the position aligned with the central axis; moving the cartridge from the axis offset from the central axis to the position aligned with the central axis; and deploying the second hollow organ and coupler into the hole to create the anastomosis.
The punch preferably comprises a shaft disposed along the central axis; and a punch tip disposed at a distal portion of the shaft and having a pointed surface for piercing the first hollow organ, in which case the method further comprises retracting the pointed surface of the punch tip into a lumen of the shaft. Preferably, the punch tip has a proximal edge for cutting the wall of the first hollow organ and a grooved portion proximate to the punch tip, in which case the method further comprises: capturing the wall of the first hollow organ in the grooved portion; and retracting the punch tip to sandwich the wall between the proximal edge and a portion of the housing to sever the wall around a periphery of the proximal edge.
Preferably, the method further comprises sealing liquid in the first internal organ from entering the device and splitting the cartridge and seal subsequent to deployment of the second hollow organ and coupler for facilitating release of the second hollow organ from the device.
The coupler preferably has pins for securing the second hollow organ to the hole of the first hollow organ, the pins being biased in a bent position, in which case the method further comprises retaining the pins in a substantially straight position prior to deployment of the second hollow organ and coupler. The method also preferably further comprises; pushing a distal end of the second hollow organ and the coupler into the hole of the first hollow organ; and releasing the restraint on the pins thereby fixing the second hollow organ to the hole of the first hollow organ. Preferably, a screw tube is rotatably disposed in the housing and operatively connected to the cartridge, wherein the releasing comprises rotating a knob connected to a distal end of a screw tube to release the restraint on the pins. Preferably, the method also further comprises restraining the rotation of the knob in the direction that releases the restraint on the pins and releasing the restraint and allowing the knob to be reset to an initial position for subsequent operations of the device.